Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism

NCT02789839 | Completed

• 1 other identifier: PHAO 2016 - OH / HEALTHOX
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell. The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27). Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.

Conditions

redOx Metabolism

Outcome Measures

Primary Outcomes (1)

• Number of oxygene reactive species

  Number of oxygene reactive species by flow cytometry

  12 months

Study Arms (1)

Healthy volunteer

EXPERIMENTAL

Blood test Medullar test

Procedure: Blood test; Procedure: Medullar test

Interventions

Blood test PROCEDURE

Blood test of 30mL

Healthy volunteer

Medullar test PROCEDURE

Medullar test for 2-5mL and a smear

Healthy volunteer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Age ≥ 18 years old and ≤ 85 ans
• Informed and written consent
• Affiliation to Social Security

You may not qualify if:

• Subject with an history of hematologic disease
• Subject with an history of tumoral disease with chemotherapy or radiotherapy
• Subject with an history of infectious or inflammatory disease
• Subject taking a treatment in prevention of blood clots
• Subject under guardianship or protection measure
• Subject with in the last 30 days food supplement rich in antioxidant : ascorbic acid, trace elements, etc…
• Subject with in the last 30 days treatment with known effect on oxydative metabolism : N-Acetyl-Cysteine, etc…
• Participant to a drug study
• Pregnant woman

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

CHRU Tours

Tours, 37044, France

Location

Related Publications (1)

• Guermouche H, Ravalet N, Gallay N, Deswarte C, Foucault A, Beaud J, Rault E, Saindoy E, Lachot S, Martignoles JA, Gissot V, Suner L, Gyan E, Delhommeau F, Herault O, Hirsch P. High prevalence of clonal hematopoiesis in the blood and bone marrow of healthy volunteers. Blood Adv. 2020 Aug 11;4(15):3550-3557. doi: 10.1182/bloodadvances.2020001582.

  PMID: 32761230 RESULT

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Olivier HERAULT, PhD

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 3, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)